Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders of Consciousness

NCT05682248 | Enrolling By Invitation DMC

• 1 other identifier: 2021ZD0204305
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

Conditions

Disorder of Consciousness

Keywords

TMS; Non-invasive neuromodulation; Brain Function Test

Outcome Measures

Primary Outcomes (6)

• Change from Coma recovery scale-revised（CRS-R）

  CRS-R scale includes 6 dimensions such as audiovisual, arousal level, verbal response, motor and communication, scoring 0 to 23, the higher the score the better the neurological function, and each score reflects the presence or absence of the evaluated person and the strength of consciousness

  Assessment within 24 hours before, and 1 hour after TMS treatment

• Change from the p300 in electroencephalogram

  Assessment the p300 in event related potential(ERP)

  Assessment within 24 hours before, and 1 hour after TMS treatment

• Change from resting-state in electroencephalogram

  Assessment the spectral power and coherence by in resting-state EEG

  Assessment within 24 hours before, and 1 hour after TMS treatment

• Change from TEP in electroencephalogram

  Assessment the TMS Evoked Potential(TEP)

  Assessment within 24 hours before, and 1 hour after TMS treatment

• Change from PCI in electroencephalogram

  Assessment the perturbational complexity index(PCI) in TMS-EEG

  Assessment within 24 hours before, and 1 hour after TMS treatment

• Change from ROI in neuroimage techniques-PET

  The distribution of 18F-FDG in the brain was analyzed according to the imaging situation, and the brain regions of interest (ROI) were outlined, and the uptake of 18F-deoxyglucose (FDG) in the patients was observed according to the brain ROI.

  Assessment within 24 hours before ,and 1 hour after TMS treatment

Study Arms (2)

Real rTMS group

EXPERIMENTAL

True rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 10 days;

Device: Transcranial magnetic stimulation

Sham rTMS group

PLACEBO COMPARATOR

sham stimulation group : intensity :0; other parameters are the same as true rTMS stimulation

Device: Sham Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation DEVICE

Transcranial magnetic stimulation

Real rTMS group

Sham Transcranial magnetic stimulation DEVICE

Sham Transcranial magnetic stimulation

Sham rTMS group

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Tianjin University: collaborator
• Jilin University: collaborator

Study Sites (1)

Xuan Wu hospitial, capical medical university

Beijing, China

Location

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: January 12, 2023
• Study Start: April 13, 2022
• Primary Completion: August 1, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)